When healing comes from the heart for your heart: Quality & Evidence matters

Cardiovascular diseases (CVDs) has become the leading cause of deaths globally as well as in India, with the disease contributing to a quarter of all deaths in the country. Compounding the problem is the early onset of disease in the population, affecting both young and old alike.


Recently, ET met with one of the pioneers in interventional cardiology Dr Rajesh Dave, Chief of Cardiology at Holy Spirit Hospital, USA at C3 conclave Gurugram, India. Dr Dave is known for his vast clinical experience and research on cardiovascular diseases. Here are the excerpts from our interaction:


There are lot of innovations ongoing in the field of interventional cardiology. For the benefit of readers, please share some insights on the recent advancements in this field.


Interventional cardiology is rapidly evolving and newer innovations are helping the physicians to optimize treatment for achieving superior clinical outcomes. There is an emerging concept of precision PCI where patients are getting benefited with innovative tools in imaging and physiology technologies like Fractional Flow Reserve (FFR) and Optical Coherence Tomography (OCT). They help in clinically assessing and perfecting the treatment decision for better results.


Blockages in coronary arteries restrict the blood flow thereby resulting in poor supply of oxygen to the heart muscles and increase in the blood pressure in the arteries. FFR is a very helpful and guiding tool used world over for assessing whether the artery needs to be stented or not. It is the first line of assessment in countries like USA, Japan and other developed countries and has the highest level of evidence and part of International guidelines.


The other technique, OCT is a high-definition imaging technology which gives a detailed 3D views of the inside of artery & helps visualize the disease inside the vessel. OCT helps in planning of interventional strategies and optimization before & after the stent deployment, and especially useful in complex diseases.


The integration of these technologies is immensely beneficial for the patients as they primarily help in scientifically assessing and perfecting the treatment decision for the patient, resulting in long term clinical benefits


For improving the patient's clinical outcome, how important is the quality of life-saving medical devices to you?


Quality and efficacy mark the foundation of any healthcare system. As a physician, it is my responsibility to deliver the best quality treatment to my patients. It is imperative to prioritize the use of quality devices for patient treatment. For instance, use of a low quality device may necessitate a re-procedure leading to additional economic burden and impacting patients lifestyle. Thus, to provide quality care to the patient, we should use the best of the devices in the first go to avoid complications in the later stages.


Recently we have seen clinical trials coming from some of the Indian stent companies claiming they are equal to MNC’s stents? What’s your thoughts on the same?


It is encouraging to see few Indian stent companies initiating clinical trials and built data around their stents. This is indeed a significant step, however the journey has just begun for them. They need to continue investment in R&D and large clinical trials to at least prove their equivalence to FDA approved stents. In USA, we have only 5 FDA approved stents and that is due to the stringent approval process where as in India we have more than 50 plus brands.


Many of the MNC stents have data from clinical trials that has enrolled 1000s of patients including those with more complex lesions. For example, the Xience stent (Abbott) has robust clinical data with 1000+ publications in all types of real world complexities like diabetes, total occlusions, acute coronary syndrome, acute MI, bifurcations, restenosis and many more. It has been studied in 100 + clinical trials of over 100,000 patients (including a large number of Indian patients) and over 10 + years of experience and that’s why it’s considered as the gold standard stent. We had stated in many of these publications that the everolimus eluting stent (such as Xience) should be the benchmark for efficacy and safety. As such, Indian stent companies should continue to conduct clinical trials to back their claim that they are equal to stents with established profile over the last decade.


In my opinion choice of the stent should be guided by clinical evidence. I go with the one with best efficacy and safety data established in large trials and complex subsets of patients.


As caregivers, it is our duty to treat our patients with utmost care and quality treatment. A robust healthcare system of any country consisting policy makers, hospitals and physicians must ensure that they provide best treatment modalities to all. After all, Every Patient Deserves the best.

(Brand Connect Initiative)